COPDNCT04252235
Home Air Purification for Eosinophilic COPD
A study testing Air purifier in people with COPD and Eosinophilia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study evaluates the influence of home air purification on the lung health of adults with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA filters) and half will receive sham air purifiers. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Eosinophilia
- What is being tested?
- Air purifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 40 years or more
- Physician diagnosis of COPD [Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted) <80%]
- Blood eosinophil count of >=150 cells per μL at screening or in the previous year
- Former smoker with tobacco exposure of >=10 pack-years
Who cannot join
- Inability to complete monthly questionnaires
- Inability to perform lung function testing
- Regularly using a portable HEPA air purifier in the home at time of enrollment
- End stage chronic disease with life expectancy <2 years as determined by PI judgment
- Living in location other than home (e.g. long term care facility)
- Planning to change residence within the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
This study evaluates the influence of home air purification on the lung health of adults with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA filters) and half will receive sham air purifiers.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is the third most common cause of death in the United States, and is exacerbated by exposure to air pollution. Knowledge about whether air purification affects the health of those with eosinophilic COPD (approximately 40% of all COPD patients seeking care), who generally have more active airway inflammation. If found to be beneficial, home air purification may offer a non-pharmacologic intervention for a large proportion of people with this common and serious disease.
This study will evaluate whether home air purification affects lung function, respiratory symptoms, nasal biomarkers (inflammatory proteins and metals) among people with eosinophilic COPD. Participants will be randomized to receive real or sham air purifier in the bedroom and living room for 12 months. The intervention group will receive two high efficiency particulate air (HEPA) air purifiers, while the control group will receive two sham air purifiers that look and sound the same as real HEPA air purifiers.
- Conditions
- COPD, Eosinophilia
- Being tested
- Air purifier, Sham air purifier
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air purifierDevice
The intervention is the placement of active HEPA air purifiers in the bedroom and living room of the true air purifier arm. These air purifiers have been shown to reduce levels of particles in the home.
Sham air purifierDevice
The intervention is the placement of sham HEPA air purifiers in the bedroom and living room. These purifiers look identical to real HEPA air purifiers, but do not filter the air.
| Study group | Role | What they receive |
|---|---|---|
| Sham air purifier | Sham comparator | Participants will receive a sham air purifier that will be installed in the bedroom and living room. These purifiers will make a noise, but will not filter the air. Receives: Device: Sham air purifier |
| True air purifier | Experimental | Participants will receive a HEPA air purifier in the bedroom and living room. Receives: Device: Air purifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in forced expiratory volume in 1 second (FEV1)
FEV1 is the volume of air exhaled in the first second of a forced exhalation maneuver. Lower volumes indicate worse lung function.
Measured: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]
Secondary outcomes (3)
Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire
The St. George's Respiratory Questionnaire is scored from 0 to 100. Higher scores indicate more health impairment.
Measured: Baseline [3 months before intervention and day of intervention] and post-intervention [6 months and 12 months]
Change in respiratory symptoms
The Breathlessness, Cough and Sputum Scale measures the severity of respiratory symptoms in COPD. The total score ranges from 0 to 12, with higher scores indicating greater symptom severity.
Measured: Monthly for 3 months preintervention and 12 months post-intervention
Change in functional capacity by 6 minute walk test
Baseline and 12 months post-intervention
Measured: The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Mar 2021
- Primary completion20 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive real or sham HEPA filters in the bedroom and living room for a total of 12 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Responsible party
- Principal investigator, Mary Rice, Beth Israel Deaconess Medical Center
- Investigators
- Mary B Rice, MD MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252235
- Sponsor's protocol ID
- 2019P001129
- Status last verified
- Oct 2026
- First submitted
- 30 Jan 2020
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: After study completion, data requests for post-hoc analyses may be submitted to the PI who will discuss each request with members of the research team and External Advisory Committee. If approved, we will facilitate secure access to data with appropriate coding files that will allow interpretation of the dataset. We will utilize data-sharing agreements to restrict the transfer of data, requiring that data be used only for research purposes. If excessive data preparation is needed, we will request funds from the requester to cover the additional personnel and resource costs.
Publications
Saeed MS, Denoncourt CM, Chao IA, Schortmann S, Nassikas NJ, Synn AJ, Koutrakis P, Coull BA, Kang CM, Wolfson JM, Ferguson ST, Rebuli ME, Jaspers I, Liu JP, Greco KF, Phipatanakul W, Rice MB. Protocol for the air purification for eosinophilic COPD study (APECS): a randomised controlled trial of home air filtration by HEPA. BMJ Open. 2024 Jan 18;14(1):e074655. doi: 10.1136/bmjopen-2023-074655.
PubMed 38238060
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Home Air Purification for Eosinophilic COPD
- ClinicalTrials.gov ID
- NCT04252235
- Acronym / sponsor ID
- 2019P001129
- Conditions
- COPD, Eosinophilia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 20 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the influence of home air purification on the lung health of adults with eosinophilic COPD. Half of the participants will receive real air purifiers (HEPA filters) and half will receive sham air purifiers.
Detailed description
Chronic obstructive pulmonary disease (COPD) is the third most common cause of death in the United States, and is exacerbated by exposure to air pollution. Knowledge about whether air purification affects the health of those with eosinophilic COPD (approximately 40% of all COPD patients seeking care), who generally have more active airway inflammation. If found to be beneficial, home air purification may offer a non-pharmacologic intervention for a large proportion of people with this common and serious disease.
This study will evaluate whether home air purification affects lung function, respiratory symptoms, nasal biomarkers (inflammatory proteins and metals) among people with eosinophilic COPD. Participants will be randomized to receive real or sham air purifier in the bedroom and living room for 12 months. The intervention group will receive two high efficiency particulate air (HEPA) air purifiers, while the control group will receive two sham air purifiers that look and sound the same as real HEPA air purifiers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive real or sham HEPA filters in the bedroom and living room for a total of 12 months.
| Arm | Type | Receives |
|---|---|---|
| Sham air purifier | Sham comparator | Device: Sham air purifierParticipants will receive a sham air purifier that will be installed in the bedroom and living room. These purifiers will make a noise, but will not filter the air. |
| True air purifier | Experimental | Device: Air purifierParticipants will receive a HEPA air purifier in the bedroom and living room. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 40 years or more
- Physician diagnosis of COPD [Global Initiative for Obstructive Lung Disease (GOLD) Stage II-IV disease with Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC) ≤70% and FEV1 (% predicted) <80%]
- Blood eosinophil count of >=150 cells per μL at screening or in the previous year
- Former smoker with tobacco exposure of >=10 pack-years
Key exclusion criteria (6 listed)
- Inability to complete monthly questionnaires
- Inability to perform lung function testing
- Regularly using a portable HEPA air purifier in the home at time of enrollment
- End stage chronic disease with life expectancy <2 years as determined by PI judgment
- Living in location other than home (e.g. long term care facility)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air purifierThe intervention is the placement of active HEPA air purifiers in the bedroom and living room of the true air purifier arm. These air purifiers have been shown to reduce levels of particles in the home. | Device | True air purifier |
| Sham air purifierThe intervention is the placement of sham HEPA air purifiers in the bedroom and living room. These purifiers look identical to real HEPA air purifiers, but do not filter the air. | Device | Sham air purifier |
Primary outcome
Change in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]
FEV1 is the volume of air exhaled in the first second of a forced exhalation maneuver. Lower volumes indicate worse lung function.
3 secondary outcomes
Change in health status (also called health-related quality of life) by St. George Respiratory Questionnaire
Time frame: Baseline [3 months before intervention and day of intervention] and post-intervention [6 months and 12 months]
Change in respiratory symptoms
Time frame: Monthly for 3 months preintervention and 12 months post-intervention
Change in functional capacity by 6 minute walk test
Time frame: The 6 minute walk test measures distance (in meters) walked in a time of 6 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Derived from this study: PubMed 38238060Saeed MS, Denoncourt CM, Chao IA, Schortmann S, Nassikas NJ, Synn AJ, Koutrakis P, Coull BA, Kang CM, Wolfson JM, Ferguson ST, Rebuli ME, Jaspers I, Liu JP, Greco KF, Phipatanakul W, Rice MB. Protocol for the air purification for eosinophilic COPD study (APECS): a randomised controlled trial of home air filtration by HEPA. BMJ Open. 2024 Jan 18;14(1):e074655. doi: 10.1136/bmjopen-2023-074655.
- Individual participant dataSharing planned: Yes. After study completion, data requests for post-hoc analyses may be submitted to the PI who will discuss each request with members of the research team and External Advisory Committee. If approved, we will facilitate secure access to data with appropriate coding files that will allow interpretation of the dataset. We will utilize data-sharing agreements to restrict the transfer of data, requiring that data be used only for research purposes. If excessive data preparation is needed, we will request funds from the requester to cover the additional personnel and resource costs.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary B Rice, MD MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air purifier in people with COPD and Eosinophilia, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in forced expiratory volume in 1 second (FEV1) (time frame: Baseline [3 months before intervention and day of intervention] and post intervention [7 days, 6 months and 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04252235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.